FDA Registration
Active
🇱🇻 Latvia
SIA TONUS ELAST / TONUS ELAST LLC.
Reg #: 3011240418
·
FEI: 3011240418
·
Expires 2026
Products
12
Proprietary Names
82
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- SIA TONUS ELAST / TONUS ELAST LLC.
- Registration Number
- 3011240418
- FEI Number
- 3011240418
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Dienvidkurzemes nov, Pilskalni
- City
- Grinvalti,Nicas pag Nicas Novads
- Country
- LV
Owner / Operator
- Firm Name
- SIA Tonus Elast /Tonus Elast, LLC.
- Operator Number
- 10057284
- Address
- Dienvidkurzemes nov, Pilskalni
- City
- Grinvalti, Nicas pag
- State
- LV-NOTA
- Postal Code
- LV-3473
- Country
- LV
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2026-04-03 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2021-06-22 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2018-03-15 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2018-03-16 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2026-04-03 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2026-04-03 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2018-03-16 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2018-03-16 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2018-05-09 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 2021-06-22 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2026-04-03 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2026-04-03 |
Proprietary Names
ELAST 9901 AIR
Neoprene medical elastic bandage for splinting of the finger of the hand, with a rigid insert (Finger Splint)
Tennis Elbow Splint (Elbow Splint)
ELAST 0001
ELAST 9901 Comfort
TONUS 0511-01 Elastic medical belt for umbilical hernia treatment
TONUS 0511 Elastic medical belt for inguinal hernia treatment
TONUS 0511D-01 Elastic medical belt for umbilical hernia
ELAST 0211 LUX
ELAST 0110 Medical elastic orthopedic arm support.
ELAST 9605
TONUS 0012 Elastic medical belt
TONUS 0012 Medical elastic lumbar fixation corset.
ELAST 0008 Irena Elastic medical maternity belt, with cotton
TONUS 9909-01 Medical elastic neoprene lumbar fixation corset.
ELAST 9806 Gerda Elastic medical maternity belt, universal
TONUS 0012-02 AIR Medical elastic lumbar fixation corset from breathable and durable material with metal inserts and
TONUS 0012-01 Medical elastic lumbar fixation corset with stiff inserts and straps for regulating compression
TONUS 9509-01 Warming medical elastic lumbar bandage
ELAST 0009 Kira Comfort Elastic medical maternity belt, with advanced back support
ELAST 9806 Gerda LUX Elastic medical maternity belt, with extra soft inner layer
TONUS 0312 Medical elastic neoprene lumbar fixation corset with straps for regulating compression.
TONUS 9509-AM Warming medical elastic lumbar bandage with angora and merino wool.
TONUS 9509 Warming medical elastic lumbar bandage
TONUS 0012-01 AIR Medical elastic lumbar fixation corset from breathable and durable material
TONUS 0012-01 LUX Medical elastic lumbar fixation corset with metal inserts and removable straps for regulating compress
with metal inserts and straps for regulating compression, reinforced
TONUS0012-01Comfort Medical elastic lumbar fixatio corsetwith metal insertsandstraps for regulating compressionreinforce
straps for regulating compression, reinforced
ELAST 9806 Gerda AIR Elastic medical maternity belt, made of wear-resistant breathable material
ELAST 0107 Comfort
ELAST 0108-01 AIR
ELAST 0107 AIR
ELAST 0108 Comfort
ELAST 0401 LUX 2 Medical compression knee-high stockings, unisex
ELAST 0403 LUX 2 Medical compression thigh-high stockings without toe, unisex
ELAST 0408 LUX 2 Medical compression knee-high stockings without toe, unisex
Articles ELAST 469 Medical compression tights
Articles ELAST 0401 Soft Elastic medical compression knee stockings with toecap ,unisex
Articles TONUS 0403 LUX Elastic medical compression arm sleeve
Articles ELAST 0401 Cotton Elastic medical compression knee stockings with toecap, with cotton, unisex
Articles ELAST 0402 LUX Elastic medical compression thigh stockings with toecap, unisex
Articles ELAST 0401 TRAVEL Elastic medical compression long socks, with toecap
Articles ELAST 0403 Hospital Elastic medical compression thigh stockings with inspection opening, anti embolism, unisex
Articles ELAST 0408 LUX Elastic medical compression knee stockings without toecap, unisex
Articles ELAST 0408 Elastic medical compression knee stockings without toecap, unisex
Articles ELAST 0401 LUX Elastic medical compression knee stockings with toecap, unisex
Articles ELAST 0404 Elastic medical compression tights
Articles ELAST 0404 LUX MAX Elastic medical compression tights for larger hip sizes
Articles ELAST 0404 LUX Elastic medical compression tights
;Articles ELAST 0403 LUX Elastic medical compression thigh stockings without toecap, unisex
Articles ELAST 0402 Soft Elastic medical compression thigh stockings with toecap, unisex
Articles ELAST 0402 Elastic medical compression thigh stockings with toecap, unisex
Articles ELAST 0402 DR Elastic medical compression thigh stockings, patterned, with toecap
Articles ELAST 0403-01 LUX Elastic medical compression mono-stockings without toecap, with fastener on the waistline, unisex
Articles ELAST 0408 Hospital Medical compressive long socks without toecap, unisex, anti-embolic
Articles TONUS 0403-01 LUX Elastic medical compression arm sleeve with shoulder strap
Articles ELAST 0401 Active Elastic compression knee stockings for active lifestyle, unisex
Articles ELAST 0405 LUX Medical elastic compression tights for pregnant women
Articles ELAST 0403-01 Hospital Elastic medical compression mono-stocking with inspection opening
Articles ELAST 0404 Soft Elastic medical compression tights
Articles ELAST 0408 01 Active Elastic compression calf sleeves active lifestyle, unisex
Articles ELAST 0408 02 Active Elastic compression calf sleeves active lifestyle, with foot straps, unisex
Articles ELAST 0404 DR Elastic medical compression tights, patterned
Articles ELAST 0401 Elastic medical compression knee stockings with toecap, unisex
Articles ELAST 0402 LUX MAX Elastic medical compression thigh stockings for larger thigh sizes
Articles TONUS 0403-02 LUX Elastic medical compression arm sleeve with shoulder strap and gauntlet
Articles ELAST 0401 Business Elastic medical compression knee stockings, with pattern, with toecap
Articles ELAST 0402 LUX DR Elastic medical compression thigh stockings, patterned, with toecap
Articles ELAST 0404 LUX DR Elastic medical compression tights, patterned
ELAST 0403 Active Elastic compression thigh stockings for active lifestyle, unisex
ELAST 0403 Soft Elastic medical compression thigh stockings without toecap, unisex
Model No. 0401 3Hearts
ELAST 0408 Soft Elastic medical compression knee stockings without toecap, unisex
ELAST 0402 3Hearts
0401 Casual -Medical elastic compression knee-high stockings, closed toe, Class I compression
ELAST 0402 LUX 2 Medical compression thigh-high stockings, unisex
Application FDA _listing_2021_06_TE_prod)
ELAST 0310-01
ELAST 0002
ELAST 9903 LUX
ELAST 9903
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)